Compact self-contained automated MDI adapters or units for ventilators

ABSTRACT

A system for providing automated delivery of medication to a ventilator circuit that extends between a mechanical ventilator and a patient includes a connector that resides in-line with a portion of the ventilator circuit, a portable medication delivery unit attached to the connector, and a control device in communication with the portable delivery unit. The portable delivery unit includes a housing releasably holding at least one metered dose inhaler canister containing medication and an actuator held by the housing and in communication with the canister to direct the canister to release medication to the ventilator circuit for the patient. The control device is configured to control an amount and/or frequency of medication delivery from the canister to the ventilator circuit for a respective patient and to direct the actuator to actuate to deliver the medication from the canister to the ventilator circuit at a defined amount and/or frequency.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/110,436, filed May 18, 2011, which claims priority from U.S.Provisional Application No. 61/345,730, filed May 18, 2010, thedisclosures of which are hereby incorporated herein in their entireties.

FIELD OF THE INVENTION

This invention relates to ventilators and to drug delivery systems.

BACKGROUND

Mechanical ventilation is a method of mechanically assisting orreplacing spontaneous breathing when patients cannot do so. One type ofventilation system employs the use of an endotracheal or tracheostomytube secured into a patient's upper respiratory tract. Gas ismechanically delivered to the patient via the tube. In many cases,mechanical ventilation is used in acute settings such as an intensivecare unit for a short period of time during a serious illness.Currently, the main form of mechanical ventilation is positive pressureventilation, which works by increasing the pressure in the patient'sairway and thus forcing additional air into the lungs. To aid in thetreatment of ventilated patients, aerosol medicines are aspirated insitu through an access point in the ventilator system. This process ismanual, requiring the medical professional to deliver the aerosols on aregular basis.

Automatically administering medication to mechanically ventilatedpatients may reduce healthcare costs and improve patient safety.

SUMMARY

According to some embodiments, a portable control unit for providingautomated delivery of medication to a ventilator circuit that extendsbetween a mechanical ventilator and a patient includes: a housingconfigured to releasably hold at least one inhaler containingmedication, wherein the inhaler is in fluid communication with theventilator circuit; an actuator held by the housing and in communicationwith the inhaler to direct the inhaler to release medication to theventilator circuit for a respective patient; a controller configured tocontrol an amount and/or frequency of medication delivery from theinhaler to the ventilator circuit for a respective patient and toactuate the actuator to deliver medication from the inhaler to theventilator circuit at a defined amount and/or frequency; and a displayheld by the housing for displaying parameters including the definedamount and/or frequency of medication delivery and an amount ofmedication remaining in the inhaler, wherein the controller isconfigured to dynamically update the displayed parameters.

The unit may include a user interface held by the housing to allow anoperator to input to the controller the amount and/or frequency ofmedication delivery from the inhaler to the ventilator circuit for arespective patient. The unit may include a caregiver-initiated manualoverride control in communication with the controller to direct theactuator to deliver medication from the inhaler to the ventilatorcircuit for a respective patient irrespective of the defined amountand/or frequency of medication delivery. The unit may include apatient-initiated manual override control in communication with thecontroller to direct the actuator to deliver medication from the inhalerto the ventilator circuit for a respective patient irrespective of thedefined amount and/or frequency of medication delivery. The unit mayinclude an agitator held by the housing and in communication with thecontroller and inhaler to agitate the inhaler prior to actuation of theactuator to deliver medication from the inhaler to the ventilatorcircuit.

In some embodiments, the unit is in combination with a connector thatforms a portion of the ventilator circuit and includes an entry port toreceive a nozzle of the inhaler therethrough such that medication isdelivered from the inhaler to an interior of the connector when theactuator is actuated. A gas flow sensor is disposed in the interior ofthe connector, with the gas flow sensor configured to detect a gas flowdirection through the connector and communicate the gas flow directionto the controller. The controller may be configured to actuate theactuator when the gas flow direction in the connector is from theventilator to the patient based on data detected by the gas flow sensor.The gas flow sensor may be configured to detect at least one gas flowcharacteristic of gas flowing through the connector and to communicatethe detected at least one gas flow characteristic to the controller,with the controller configured to adjust the amount and/or frequency ofmedication delivery in response to the detected at least one gas flowcharacteristic. In some embodiments, the portable control unit is acompact and/or lightweight device that attaches to the connector.

In some embodiments, the controller is configured to: (i) lock the unitto prevent actuation of the actuator and prevent unwanted adjustment ofoperational parameters; (ii) receive identification informationassociated with an operator of the unit; (iii) verify that the operatoris an authorized user based on the identification information; and (iv)unlock the unit in response to verification that the operator is anauthorized user. In some embodiments, the controller is configured to:(i) lock the unit to prevent actuation of the actuator and preventunwanted adjustment of operational parameters; (ii) receiveidentification information associated with a patient; (iii) verify thatthe patient is to receive the medication contained in the inhaler basedon the identification information; and (iv) unlock the unit in responseto verification that the patient is to receive the medication containedin the inhaler.

In further embodiments, a system for providing automated delivery ofmedication to a ventilator circuit that extends between a mechanicalventilator and a patient includes a connector that resides in-line witha portion of the ventilator circuit and a compact and/or lightweightportable control unit attached to the connector. The portable controlunit includes: a housing configured to releasably hold at least oneinhaler containing medication, wherein the inhaler includes an outletnozzle received through an entry port in the connector such that theinhaler is in fluid communication with the ventilator circuit; anactuator held by the housing and in communication with the inhaler todirect the inhaler to release medication to the ventilator circuit for arespective patient; and a controller configured to control an amountand/or frequency of medication delivery from the inhaler to theventilator circuit for a respective patient and to actuate the actuatorto deliver the medication from the inhaler to the ventilator circuit ata defined amount and/or frequency.

The unit may include a user interface held by the housing to allow anoperator to input to the controller the amount and/or frequency ofmedication delivery from the inhaler to the ventilator circuit for arespective patient. The unit may include a manual override control incommunication with the controller to direct the actuator to actuate todeliver medication from the inhaler to the ventilator circuit for arespective patient irrespective of the defined amount and/or frequencyof medication delivery.

In some embodiments, the system includes a gas flow sensor disposed inthe connector, with the gas flow sensor configured to detect a gas flowdirection through the connector and communicate the gas flow directionto the controller, wherein the controller is configured to actuate theactuator in response to the gas flow sensor detecting a gas flowdirection from the ventilator to the patient. The gas flow sensor may beconfigured to detect at least one gas flow characteristic of gas flowingthrough the connector and to communicate the detected gas flowcharacteristic to the controller, with the controller configured toadjust the amount and/or frequency of medication delivery in response tothe detected at least one gas flow characteristic. The unit may includea display for displaying parameters including the defined amount and/orfrequency of medication delivery and an amount of medication remainingin the inhaler, wherein the controller is configured to dynamicallyupdate the displayed parameters.

In further embodiments, a diagnostic system for use with a ventilatorcircuit that runs between a mechanical ventilator and a patientincludes: a first housing configured to releasably hold a containercontaining particles to be inhaled by the patient, wherein the containeris in fluid communication with the ventilator circuit; a first actuatorat least partially in the first housing and in communication with thecontainer to deliver particles to be inhaled by the patient from thecontainer to the ventilator circuit; an exhaled gas measurement sensordisposed in the ventilator circuit configured to perform a measurementon gas exhaled from the patient after the particles have been inhaled bythe patient; and at least one controller configured to actuate the firstactuator to deliver the particles to be inhaled by the patient from thecontainer to the ventilator circuit, to receive the measurement on gassubsequently exhaled by the patient from the exhaled gas measurementsensor, and to determine a current state or condition of the patient inresponse to the received measurement.

The system may further include a portable unit for providing automateddelivery of medication to the ventilator circuit, with the unitincluding: a second housing configured to releasably hold an inhalercontaining medication, wherein the inhaler is in fluid communicationwith the ventilator circuit; and a second actuator held by the secondhousing and in communication with the inhaler to direct the inhaler torelease medication to the ventilator circuit for the patient. The atleast one controller is configured to: (i) control an amount and/orfrequency of medication delivery from the inhaler to the ventilatorcircuit for the patient; (ii) actuate the second actuator to deliver themedication from the inhaler to the ventilator circuit at a definedamount and/or frequency; and (iii) adjust the defined amount and/orfrequency of medication delivery in response to the determined currentstate or condition of the patient.

The system may include a display for displaying information including atleast one of the defined amount of medication delivery and/or frequencyof medication delivery, an amount of medication remaining in theinhaler, and the determined state or condition of the patient, whereinthe controller dynamically updates the displayed information.

In further embodiments, a connector for use with a ventilator circuitthat runs between a mechanical ventilator and a patient for evenlyreleasing medication from an inhaler into the ventilator circuitincludes: an outer fluid channel in fluid communication with the inhalerand configured to contain medication from the inhaler therein; an innerfluid channel radially spaced-apart from and in fluid communication withthe outer fluid channel, wherein the inner fluid channel forms a portionof the ventilator circuit; a wall separating the outer fluid channel andthe inner fluid channel; and a plurality of perforations in the wall.When gas flows through the ventilator circuit in a direction from theventilator to the patient, medication contained in the outer fluidchannel is released through the perforations, into the inner fluidchannel, and into the gas in the ventilator circuit to the patient.

The connector may be in combination with a controller and a gas flowsensor disposed in the ventilator circuit configured to detect a gasflow direction through the ventilator circuit and communicate the gasflow direction to the controller. The controller is configured toactuate the inhaler to release medication therefrom to the outer fluidchannel after detection by the gas flow sensor of a gas flow directionfrom the patient to the ventilator and before detection by the gas flowsensor of a gas flow direction from the ventilator to the patient.

It is noted that aspects of the invention described with respect to oneembodiment may be incorporated in a different embodiment although notspecifically described relative thereto. That is, all embodiments and/orfeatures of any embodiment can be combined in any way and/orcombination. Applicant reserves the right to change any originally filedclaim or file any new claim accordingly, including the right to be ableto amend any originally filed claim to depend from and/or incorporateany feature of any other claim although not originally claimed in thatmanner. These and other objects and/or aspects of the present inventionare explained in detail in the specification set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an automated medication andcontrol delivery unit according to some embodiments.

FIG. 2 is a schematic illustration of an alternate automated medicationand control delivery unit according to some embodiments.

FIG. 3 is a schematic illustration of an alternate automated medicationand control delivery unit according to some embodiments.

FIGS. 4A and 4B are schematics of a connector for delivering medicationto a ventilator circuit according to some embodiments.

FIG. 5 is a block diagram illustrating a controller and other componentsthat may be associated with automated medication and control deliveryunits according to some embodiments.

FIG. 6 is a block diagram illustrating a processor and a memory that maybe associated with automated medication and control delivery unitsaccording to some embodiments.

FIG. 7 is a schematic of an automated medication and control deliveryunit and a patient-initiated manual control according to someembodiments.

FIG. 8 is a schematic of a diagnostic delivery device or unit, aventilator circuit and an automated medication and control delivery unitaccording to some embodiments.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention will now be described more fully hereinafter, inwhich embodiments of the invention are shown. This invention may,however, be embodied in different forms and should not be construed aslimited to the embodiments set forth herein. Rather, these embodimentsare provided so that this disclosure will be thorough and complete, andwill fully convey the scope of the invention to those skilled in theart. In the drawings, like numbers refer to like elements throughout.

Thicknesses and dimensions of some components may be exaggerated forclarity. Broken lines illustrate elements or features not visible fromthe presented view (e.g., on the opposite side) or as an optionalelement unless otherwise indicated. It will be understood that when anelement is referred to as being “attached,” “connected,” or “coupled” toanother element, it can be directly connected or coupled to the otherelement or intervening elements may be present. In contrast, when anelement is referred to as being “directly attached,” “directlyconnected,” or “directly coupled” to another element, there are nointervening elements present. Also, although a feature is described withrespect to one embodiment, this feature may be used with anotherembodiment.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items. As used herein, phrases such as “between X and Y” and“between about X and Y” should be interpreted to include X and Y. Asused herein, phrases such as “between about X and Y” mean “between aboutX and about Y.” As used herein, phrases such as “from about X to Y” mean“from about X to about Y.”

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

Turning now to the figures, an automated medication control and deliveryunit 10 is illustrated in FIG. 1. The unit 10 can be used to providecontrolled and automated delivery of an inhalable substance (e.g.,medication) to a ventilator circuit 11. The unit 10 can be a compactself-contained device. The unit 10 can be a low-cost, standalone unitthat is easy to install and operate. In some embodiments, the unit 10weighs between about 2 ounces and about 5 pounds. In some embodiments,the unit 10 weighs between about 2 ounces and about 16 ounces. In someembodiments, the unit 10 has a volume of between about 16 cubic inchesand about 64 cubic inches. As will be described in more detail below,the unit 10 may be relatively compact and lightweight for suitableconnection to the ventilator circuit 11 or a connector associatedtherewith.

As illustrated, the unit 10 is configured to receive a metered doseinhaler (MDI) device 12A, such as a pressurized MDI (pMDI) or Dry PowderInhaler (DPI). The unit 10 includes a housing 14. The MDI 12A may besnugly and releasably held by the housing 14 or by components within thehousing 14. The unit 10 may include a sensor 201 (FIG. 5), such as aproximity sensor (Hall-effect, optical, and the like) to detect whetherthe MDI 12A has been properly installed.

Also illustrated is a connector 16 that forms a part of the ventilatorflow circuit 11. In some embodiments, the connector 16 is integratedwith the unit 10 (i.e., the connector 16 is fixably attached to the unit10, and can therefore be considered part of the unit 10). The connector16 can be a tubular component with substantially the same diameter asthe proximate portions of the ventilator circuit 11. In someembodiments, and as illustrated, the connector 16 is releasably attachedto the unit 10. For example, the unit 10 may include one or morebrackets or holders 18. The holders 18 may comprise straps, fingers, orother holders. The holders 18 may adjustably surround the connector 16so as to releasably attach the connector 16 to the unit 10. In thisregard, the connector 16 may be disposable although the unit 10 may beused multiple times for different patients. Other configurations toreleasably attach the connector 16 to the unit 10 are envisioned. Asdescribed above, the unit 10 may be compact and lightweight. Thisconfiguration may facilitate connection to and disconnection from theconnector 16. Also, the lightweight nature of the unit 10 may inhibit orprevent deflection or indentation of the connector 16 when attachedthereto, and may also inhibit or prevent deflection of the connector 16relative to the remainder of the ventilator circuit 11 (e.g., downwarddeflection in FIG. 1). Thus, the lightweight design may inhibit orprevent damage to the connector 16 (e.g., crushing or indentation) andmay allow for a more consistent flow path through the ventilator circuit11 and the connector 16 (e.g., a substantially straight flow path havinga substantially even cross-section). Attaching and detaching the unit 10to the connector 16 may allowed for a self-contained unit in aconvenient location that performs the functions described below.

The MDI 12A includes a nozzle 20 with an exit port 20A (e.g., nozzle).The MDI 12A is positioned such that at least a portion of the exit port20A is positioned inside the connector 16. The connector 16 may includean entry port to sealably receive the MDI 12A nozzle 20 (or the exitport 20A). For example, the connector 16 can directly or indirectlyengage the nozzle 20 and/or the port 20A. In some embodiments, a raisedcollar (not shown) from the connector 16 can receive the MDI exit port20A and/or provide resistance against an actuator (described in moredetail below). In other embodiments, the connector 16 can include anentry port, and an extension, such as an angled elbow tube (not shown),can be fixably or releasably attached to the entry port. In any event,medication can be released from the MDI 12A to the interior of theconnector 16, and therefore through the ventilator flow circuit 11, aswill be described in more detail below.

Still referring to FIG. 1, the connector 16 includes first and secondend segments 22, 24. The connector 16 connects with the ventilator flowcircuit 11 leading to the ventilator V and the patient P. Moreparticularly, the connector 16 connects with the ventilator flow circuit11 leading to the ventilator V at or adjacent the first end segment 22and the connector 16 connects with the ventilator flow circuit 11leading to the patient P at or adjacent the second end segment 24. Atleast the first and second end segments 22, 24 may be axially and/ortransversely flexible, may be an “accordion-like” conduit or corrugatedtube, may have a telescoping form, or a combination of the same. Theseflexible configurations can allow the connector 16 to more easily andsecurely connect to the remainder of the ventilator flow circuit 11. Forexample, the end segments 22, 24 may allow for some movement of theventilator flow circuit 11 (e.g., at the patient and/or ventilator end)without compromising the sealed or tight connections to the connector16.

An actuator 202 in communication with an upper end of the MDI 12A canautomatically actuate the MDI 12A to release medication therefrom. Theactuator 202 can provide motion to open a valve of the MDI 12A such thatthe MDI 12A dispenses a metered dose of medication through the exit port20A and into the interior of the connector 16. In some embodiments, theactuator 202 takes the form of a plunger positioned above the MDI. Insome embodiments, the actuator 202 can be similar to the actuatorsdescribed in co-pending U.S. Patent Application Publication No.2008/0308101, filed Jun. 13, 2008, the contents of which areincorporated by reference as if disclosed herein in its entirety.

The unit 10 may include an agitator 203 (FIG. 5). For example, theagitator 203 may be included in the housing 14 and may contact the MDI12A. Many medications should be agitated before delivery from the MDI12A. The agitator 203 can shake or vibrate the MDI 12A in one or moredirections. For example, the agitator 203 may shake the MDIback-and-forth in a vertical direction and/or a horizontal directionand/or in any other direction. In some embodiments, the agitator 203 cancomprise a piezoelectric crystal or ceramic transducer.

The unit 10 typically includes an on-board microprocessor or controller200 (FIG. 5) contained in the housing 14. The controller 200 may beoperatively connected to and/or control, for example, an operatorinterface panel 26, a display 28, the actuator 202, and the agitator203. The controller 200 may be operatively connected to and/or controlother components and operations of the unit 10, as will be described inmore detail below.

As illustrated in FIG. 1, the operator interface panel 26 includes auser interface (UI) 261 with a plurality of user controls. An operatorcan control the number of doses to be supplied from the MDI 12A via theUI control 29. The operator can also control the frequency of thesupplied doses via the UI control 30. Thus, these controls allow theunit 10 to be programmed to selectively provide a desired, adjustableand automated delivery of medication to a respective patient from theMDI 12A to the connector 16 and therefore to the ventilator flowcircuit. The operator interface panel 26 may also include a display UIcontrol 31 and a manual override UI control 32, which will be describedin more detail below. It is noted that the UI controls could be variousinput devices such as GUIs, electronic pull-down menus, buttons, wheels,or the like. Moreover, the operator interface panel 26 can be integratedwith the display 28, which can be a GUI touch screen display with iconsor other features providing the user input, for example.

The unit 10 is configured to display certain information and operationalparameters on the display 28. For example, the doses remaining (i.e.,the number of doses input by the operator or the number of dosesassociated with the MDI 12A less the number of doses alreadyadministered) may be displayed. The number of doses need not necessarilymatch the number of actuations as a patient may need more than one “puffper dose.” In some embodiments, the unit 10 can be configured to trackand/or display the number of actuations or “puffs.” MDIs are sometimesprepackaged and pre-measured with a defined number of actuations orpuffs (e.g., 60 to 400 actuations or puffs). Because the number of puffsper dose may vary based on a patient and/or a physician's orders, theunit can track the actuations or puffs to provide information andaudible, visual or other warning as to when the MDI canister 12A will beempty or should be replaced. It is noted that although the unit 10 cantrack or measure actuations (puffs), the unit can also be programmedsuch that this information is converted to doses for a particularpatient.

The interval between doses may also be displayed on the display 28.Other information such as the “status” of the MDI 12A can also bedisplayed. For example, the status may read “on” when the MDI isoperating under an automated mode with defined programmed parameters or“off” if the MDI is not in an automated mode. The status may also informthe operator whether the MDI has been installed correctly and/or whetherthe MDI is operational in general. The controller 200 (FIG. 5) cancontinuously or at various times dynamically update the variousinformation and parameters on the display 28 based on user input and/orbased on the operation of the unit 10.

In some embodiments, all operational information can be displayed on thedisplay 28 together. Alternatively, the information may scroll along thedisplay 28 and/or the display 28 may toggle between different screenscontaining different information. The display UI control 31 may allowthe operator to manually perform these scrolling and togglingoperations. The display UI control 31 may also power the display 28 “on”and “off” in some embodiments. The display 28 may power “on” and “off”at various intervals for a power-saving mode. An “on” display mode maybe triggered by a proximity sensor or by a clinician's manual input orat selected or pre-set time intervals. The display 28 may automaticallyoperate prior to actuation and just after then go into power-savingmode.

Power may be provided to the unit 10 via a medical grade AC or DC powersupply 204 (FIG. 5). The unit 10 may include a battery 205 (FIG. 5) toallow the unit 10 to function if the AC or DC power supply isinterrupted. Alternatively, the power may be provided by an on-boardbattery 204 (FIG. 5) and the unit 10 can include one or more backupbatteries 205 (FIG. 5). It is contemplated that various components couldbe powered by different power sources. For example, the actuator 202 anddisplay 28 may be powered by different power sources.

In operation, the controller 200 (FIG. 5) can direct the agitator 203 toagitate the MDI 12A just prior to actuation and delivery of themedication from the MDI 12A based on the selected delivery frequency.The controller 200 can then direct the actuator 203 to actuate the MDI12A to dispense medication into the ventilator flow circuit 11. Thecontroller 200 typically times the actuation such that the medication isdispensed while the flow of gas through the connector 16 is toward thepatient (i.e., while the patient inhales). This flow direction isindicated by the arrows in FIG. 1.

A position sensor 206 (FIG. 5) may be associated with the actuator 202and/or with the MDI 12A such that movement of these components can bemonitored. Thus, if the actuation of the MDI 12A is downward, theposition sensor 206 may detect the delivery of a dose or puff based ondownward movement. The position sensor 206 may also sense that the MDI12A has returned to its proper position based on upward movement. Theposition sensor 206 may communicate with the controller 200 to provideinformation to the display 28 (for example, the “doses remaining” or“puffs/actuations remaining” count may be decremented).

Alternatively, a counter (e.g., dose count module 207, FIG. 5)associated with the actuator 202 can “count” the number of actuations.It is noted that two or more successive actuations could equal one dosewhere the dose is two or more “puffs” and the dose counter can indicatethe number of doses remaining. As described above, the number of puffscan also be displayed and/or monitored. Because the rate at which puffswill be delivered may be programmed, the unit 10 can further calculate,monitor and/or display the time at which the MDI canister 12A will beempty. For example, the display 28 could show the number of puffsremaining, and how many hours and minutes remain before the canister isempty (or the date and/or time at which the canister will be empty).

The controller of the unit 10 can be in communication with the connector16 or components therein. For example, there may be a gas flow sensor208 disposed in the connector 16 (or elsewhere in the ventilator circuit11) to detect incoming air from the ventilator V and exhaled breath fromthe patient P. In other words, the gas flow sensor 208 can measure orsense the direction of the flow of gas through the connector 16 (or theventilator circuit 11) and communicate the same to the controller. Asdescribed above, the release of medication from the MDI 12A is timed sothat the medication flows with the gas toward the patient. The gas flowsensor 208 may further verify that the medication properly reaches thepatient and may communicate the same to the controller.

The gas flow sensor 208, or an additional sensor, may be used to measurepressure and/or the rate of change of pressure in the ventilator flowcircuit, and may measure other gas flow characteristics such asvolumetric gas flow rate and temperature, that indicate the patient'sability to receive the medication. The gas flow sensor 208 can measureventilator flow circuit conditions and patient airway resistance, whichmay be used to determine the need for additional medication dosing andtiming or modulation of the current specified dosing and timing of themedication. Higher pressure and/or a relatively short cycle time onreversal of gas flow may indicate that the ability of the patient toconsume the medication through the lungs is impaired. In such case, thecontroller 200 may increase the dosage frequency or dosage amount to thepatient or both. The adjustment may occur manually or automatically byan algorithm utilized by the controller 200. Similarly, to wean thepatient, the frequency and/or dose amount can be reduced when patientairway resistance improves.

The unit 10 may comprise a dose release sensor 209 (FIG. 5). This sensormay verify that a dose of medication was actually dispensed anddelivered. Verification may be provided and recorded in the controller200 (e.g., in a database) or in another computer or memory storagedevice. Similarly, data from other sensors as disclosed herein may becollected and stored in the controller (e.g., in a database) or inanother computer or memory storage device.

The sensors described herein and other sensors may perform otherfunctions as described in co-pending U.S. Patent Application PublicationNo. 2008/0308101, filed Jun. 13, 2008, the disclosure of which isincorporated by reference as if disclosed herein in its entirety.Moreover, the unit 10 and/or the connector 16 may include any othercomponents described in the co-pending application and incorporated byreference herein.

The unit 10 typically includes a manual override UI control 32. Theoperator may use this control to deliver an unscheduled release ofmedication, such as if the respiratory condition of the patient appearspoor or upon an order from the doctor. The counter on the display (e.g.,“doses or puffs remaining”) will generally be decremented following useof the manual override.

The unit 10 may include other features. For example, the unit 10 mayhave a shutoff control to immediately cease the automated functions ofthe unit 10 (for example, in an emergency situation). The shutoffcontrol may be part of the operator interface panel 26 or may be aseparate switch on the unit 10.

The unit 10 may also provide alarms for various events, such as when theunit 10 is malfunctioning (e.g., one or more components have stoppedoperating) or when the MDI 12A is depleted of medication or approachingthis state. The alarms may be visible alarms on the display 28 and/oraudible alarms. The alarms may be sent to one or more of a PDA, cellphone, notepad, or other device carried by a clinician such as a nurseand/or a monitoring station.

The unit 10 may include certain features to enhance security and patientsafety. For example, the operator may need to enter a password prior tooperating the unit 10. The password may be entered via UI controls onthe operator interface panel 26, for example. The unit 10 may alsoinclude or communicate with one or more identification devices and caninclude one or more optical or electronic devices. For example, theoperator may be required to enter (e.g., swipe) or scan a badge orauthorized key fob or other identification prior to operating the unit.The unit 10 can include an on-board reader that recognizes authorizedusers via biometrics, magnetic data strips, and the like.

The unit 10 can be configured for pre-defined product data for aparticular patient. Thus, the MDI 12A may be electronically identified(e.g., via a bar code label) by the unit 10 before or duringinstallation in the unit 10 or before operation of the unit 10 to helpensure the proper medication is being administered. For example, theunit 10 can include an optical reader that electronically reads a labelon the MDI (the MDI may need to be rotated to have the correctorientation before allowing automated dispensing). Other identificationdevices, such as RFID tags, may be implemented instead of bar codes. Theunit 10 may also store information about each MDI drug and about thepatient so it can alert the operator to drug incompatibilities or toprevent programming an overdose and generally reduce drug administrationerrors.

Furthermore, the patient may be identified in a variety of ways prior toadministering medication. For example, the unit 10 can beprogrammatically locked, and the operator must identify the properpatient identification to unlock the unit 10 (e.g., after loading theMDI 12A). That is, the unit 10 may be configured to have apatient-specific code that an operator must use to operate or change theMDIs in the unit 10.

Other methods of automating and controlling the unit 10 arecontemplated. For example, the unit 10 may communicate with a wirelesshandheld device (such as a PDA, cell phone, notepad or smartphone). Thehandheld device may be used along with or instead of the user interfacepanel 26 to input parameters such as the number and frequency of doses.A display on the handheld device may display various information alongwith or instead of the display 28 associated with the unit 10.

Referring to FIG. 5, various of the above operations may be carried outat least in part at modules associated with and/or in communication withthe controller 200. For example, operations related to dose counting maybe carried out at a dose count module 207, operations related to dosefrequency may be carried out at a dosing interval module 210, andoperations related to security and safety may be carried out at asecurity module 211. Other modules can be implemented to carry out theseor other operations described herein.

FIG. 6 illustrates a processor 300 and memory 305 that may be used tocarry out at least some of the operations described herein. Thecontroller 200 (FIG. 5) may comprise the processor 300 and/or the memory305. The processor 300 communicates with the memory 305 via anaddress/data bus 310. The processor 300 may be, for example, acommercially available or custom microprocessor. The memory 305 isrepresentative of the one or more memory devices containing software anddata used to perform operations in accordance with some embodiments ofthe present invention. The memory 305 may include, but is not limitedto, the following types of devices: cache, ROM, PROM, EPROM, EEPROM,flash, SRAM, and DRAM.

As shown in FIG. 6, the memory 305 may contain an operating system 315;the operating system 315 may manage the unit's 10 software and/orhardware resources and may coordinate execution of programs by theprocessor 300.

Another embodiment of an automated control and delivery unit 10′ isillustrated in FIG. 2. The unit 10′ can include any or all thecomponents and features described above with regard to the unit 10. Theunit 10′ can be configured to automate the delivery of medication from aplurality of (shown as two) MDIs 12A, 12B. Thus, the unit 10′ mayinclude at least a second set of certain components associated with thesecond MDI 12B. For example, the unit 10′ may include two actuators, twoagitators, two sets of various sensors, two manual override UI controls32A, 32B, and the like. Alternatively, the unit 10′ can be configured sothat each MDI shares certain components (e.g., the agitator, agitator,etc.). Furthermore, the display UI control 31 may allow an operator totoggle between screens to set parameters associated with each of theMDIs 12A, 12B (e.g., the number and frequency of doses, which may bedifferent for each MDI). The operator may also use the display UIcontrol 31 to toggle between screens to view information about each MDI12A, 12B during automated operation.

It is contemplated that a unit similar to the unit 10′ may accommodatemore than two MDIs. For example, the additional MDIs may be aligned withthe MDIs 12A, 12B shown in FIG. 2. Alternatively, a second housing mayextend away from the connector 16 to accommodate additional MDIs. Forexample, a second housing may be circumferentially and/or axially spacedapart from the unit 10′ (e.g., the second housing may reside “beneath”the connector 16 illustrated in FIG. 2). By way of further example, theunit 10′ could be rotated by 90 degrees on the vertical axis, andmultiple devices could be attached onto a longer connector 16 that has arow of multiple entry ports.

Another automated control and delivery unit 10″ is illustrated in FIG.3. The unit 10″ can include any or all the components and featuresdescribed above with regard to the units 10, 10′. The unit 10″ may beconfigured such that an off-the-shelf MDI canister 12C (which may beinside a conventional inhaler housing device) can be releasably attachedto the unit 10″. The MDI 12C may be integrated with a connector 16′.Alternatively, the connector 16′ could include segment 17, and the MDIcanister 12C could be attached to the segment 17 to communicate with theconnector 16′. Holders 18 may releasably secure the MDI 12C and/or theconnector 16′ to the unit 10″. The unit 10″ can be used withconventional spacers, adapters and/or MDI canisters. In someembodiments, the unit 10″ is a self-supported device.

The units 10, 10′, 10″ may be used in concert with a heat and moistureexchange (HME) device. HME devices are not always used in ventilatorcircuits, but their use is well known to those of skill in the art. Thedesigns disclosed herein allow attachment of the MDIs to HME devices.

The units 10, 10′, 10″ may include a memory, such as the memory 305(FIG. 6) or other memory, to allow data acquisition capability. Inparticular, the memory may provide for data capture such that data canbe downloaded. The unit can include a USB interface, an Ethernetinterface, wireless transmission capabilities, Bluetooth or otherconnectivity to transmit data to an outside device 215 (FIG. 5). Thecontroller 200 or processor 300 may control the transmission of datafrom the memory to the outside device 215. The memory may also beprovided as a removable memory device, such as a memory stick or thelike. The data may then be used for patient records, for assessing theperformance of the unit, and for other purposes as would be understoodby those of skill in the art.

It is noted that the outside device 215 can be used for other functions,such as entering desired operational parameters, viewing informationassociated with the unit, receiving alarms, providing security,upgrading software, and other operations described herein. In thisregard, the outside device 215 may communicate with the controller 200.

In the embodiments described above, medication from an MDI such as theMDI 12A is typically injected into the ventilator flow circuit 11 viathe interior of the connector 16. In some other embodiments, theconnector may take a different form, for example the form shown in FIGS.4A and 4B. As illustrated, the connector 160 includes inner and outerfluid channels 160A, 160B. The channels 160A, 160B are separated by awall 160W including a plurality of small openings, apertures orperforations 160P. In the illustrated embodiment, the channels 160A,160B are concentric and the wall 160W takes the form of a cylinder, butother shapes and configurations are envisioned. It is noted that the“ends” of at least the outer channel 160B could be sealed or terminateeither at or before the points at which the connector 160 connects withthe remainder of the ventilator flow circuit.

In operation, an inhaler 12D is actuated such that medication can beinjected into an intermediate passageway 160I of the connector 160, asshown by the dashed arrows in FIG. 4A. The medication then flows intothe outer channel 160B, as further shown by the dashed arrows. In someembodiments, the medication can be injected directly into the outerchannel 160B. Thus, the medication (usually in the form of a mist orparticles) is injected into and, in some embodiments, temporarily“stored” in the intermediate passageway 160I and/or the outer channel160B. In other words, the intermediate passageway 160I and/or the outerchannel 160B can be thought of as a “holding chamber,” and the timing toactuate the MDI 12D may not be as critical.

The medication is drawn from the outer channel 160B, through theperforations 160P, and into inner channel 160A, and therefore drawn intothe ventilator flow circuit. This may be accomplished via a Venturieffect. In particular, the pressure in the inner channel 160A drops whengas from the ventilator circuit 11 flows therethrough. A pressuregradient between the outer chamber 160B and the inner chamber 160Acauses medication particles to be pulled through the perforations 160Pand delivered to the patient. The plurality of perforations 160P canhelp ensure that the medication is evenly dispersed.

Thus, it is envisioned that the release of medication from the MDI 12Dis timed so that the medication flows with the gas toward the patient.In some embodiments, the release of medication to the intermediatepassageway 160I and/or to the outer channel 160B is timed after the flowof gas from the patient to the ventilator (i.e., after an “exhale”).

Other configurations are envisioned. For example, the perforations 160Pmay be covered during the ventilator cycle except when the flow of gasis toward the patient, at which point they are automatically uncovered.A movable sheath or sleeve can provide the desired open/closeconfigurations. The sheath can rotate or slide axially to perform thisfunction. The sheath can be positioned on the outer surface over theperforations 160P or inside the wall 160W. In other embodiments, a valvemay controllably release the medication to the inner chamber 160A onlywhen the proper flow direction is realized. For example, the proper flow(i.e., toward the patient) may actuate the valve and/or uncover theperforations to release the medication. Alternatively, a flow sensor,such as the gas flow sensor 208 described above, may detect the flowdirection and/or rate and accordingly the valve may be actuated and/orthe perforations may be uncovered responsive to detection by the sensor.In some embodiments, the valve may be positioned between theintermediate passageway 160I and the outer channel 160B, such thatmedication may be released to the outer channel 160B when the valveopens.

Alternatively or additionally, actuation of the inhaler 12D may be timedbased on the flow direction through the inner channel 160A. That is, thegas flow sensor 208 may detect a gas flow in the inner channel 160A orthe ventilator circuit 11 that is in the direction from the ventilatorto the patient. The sensor 208 may detect that this flow has ceased, oris about to cease, at which point actuation of the inhaler 12D may occurand medication may be delivered into the outer channel 160B and/or theintermediate passageway 160I. In this regard, as the gas flow direction“reverses” to a direction from the ventilator to the patient, themedication may be “staged” for release into the inner channel 160A andthe ventilator circuit 11.

The system shown in FIGS. 4A-4B may be integrated into or operate withthe units 10, 10′ and 10″. Furthermore, any features or componentsdescribed in reference to FIGS. 4A-4B could be operatively connected toand/or controlled by the controller 200 described above. Thus, theadapter or connector 160 may be used in conjunction with automateddelivery units described herein or may simply be used with an inhalerdevice, such as an MDI.

As described above, the units may include at least one manual overridecontrol (e.g., control 32 of the unit 10 illustrated in FIG. 1). Thiscontrol may allow a caregiver to administer one or more sprays on demandindependent of the current or programmed dosing schedule.

In some embodiments, the unit may be designed with the option to allowthe patient the ability to self-administer an unscheduled “puff” or doseof medication. For example, referring to FIG. 7, a patient P (such as amechanical ventilator patient) may have access to a manual overridecontrol 132. The manual override control 132 may be attached to orintegrated into a hospital bed or may be a device placed within reach ofthe patient P, such as a control with a depressible button or the like.The control 132 may allow the patient P to self-administer anunscheduled “puff” or dose of medication whenever the patient P sensesthe need and without having to call a caregiver. This may be usefulbecause mechanical ventilator patients generally cannot easilycommunicate their needs. For example, this feature may be useful forcritical but non-sedated patients.

The manual override control 132 is in communication with unit 10′″ suchthat when the patient P actuates the control 132, the unit 10′″ mayrespond by administering a dose or “puff” of medication. The control 132and the unit 10′″ may be directly electrically coupled (e.g., by a cableor wire) and/or the control 132 may be in wireless communication withthe unit 10′″. In particular, a controller 200 of the unit 10′″ (FIG. 5)may respond to a signal from the manual override control 132 and thenmay agitate and/or actuate an MDI to release a puff or dose to theventilator flow circuit.

The unit 10′″ may include both a manual override control for use by aclinician or caregiver (e.g., the control 32 on the unit 10 illustratedin FIG. 1) and the manual override control 132 for use by the patient P.The unit 10′″ may include a display with a counter indicating the dosesor puffs remaining, and the counter can be decremented when either apatient-initiated or caregiver-initiated manual override is performed.

The unit 10′″ may include safety control of patient-initiated drugdispensation within safe parameters as determined by a physician and/orprogrammed by the unit operator. For example, the unit 10′″ may beconfigured to limit the number of manual overrides that may be performedby the patient P within a given timeframe. The limit can be set based onthe medicine and/or the patient. The limit can be programmably adjustedvia a local or remote input. The unit 10′″ may include a visualindicator (e.g., on a display) and/or may emit an audible signal oralarm each time the patient P uses the manual override or at certainthresholds according to the patient P using the manual override.Moreover, the unit 10′″ may include a visual indicator (e.g., on adisplay) and/or may emit an audible signal or alarm when the patient Pis approaching or has reached the programmed limit of manual overrideswithin a given time period. A display and/or memory associated with theunit 10′″ may document the number of patient-initiated manual overridesthat have been attempted (and may document the time each override wasattempted). The display and/or memory may also document whethermedication was dispensed each time the manual override was attempted.

Turning to FIG. 7, a diagnostic device 100 is illustrated. The device100 may be advantageously used as a driver for early disease detection,reduction of healthcare costs, and/or speedier and/or more effectivetreatment through personalized care to promote better patient safety andoutcome. As will be described below, the device 100 may take the form ofone or more of the units 10, 10′, 10″, 10′″ described herein.Alternatively, the device 100 may be a smaller version and/or may omitcertain features of these previously described units. The device 100 maybe a standalone unit and may be used in conjunction with one of theunits 10, 10′, 10″, 10′″ described herein.

The device 100 may provide a diagnostic platform and may be used withpatients in vivo. The device 100 provides for the administration ofinhaled particles, whether they be small chemical agents, smallpeptide/proteins, whole organisms such as a virus vector, or aradioactive labeled particles (e.g., nucleotide/carbohydrate/gas) thatcan be thought of as a “drug or pharmaceutical agent.” This agent may beused for a clinical effect to measure, diagnose, and/or treat anyphysiologic process or condition by measuring the exhaled gas to make aphysiological reading or measurement to determine a specific state orcondition. The device 100 may then use the measured specific state basedon the pre-determined/programmed protocol to automatically initiatespecified care/treatment (e.g., inhaled antibiotics/inhaledsteroids/radioactive gold particles or initiate ventilator weaning) inan automated fashion based on the disease state/condition and/or thephysiologic parameter that is chosen to be measured. In variousembodiments, the device 100 may be used for only administrationpurposes, for only detection purposes, and for both administration anddetection purposes. In some embodiments, the detected condition or statemay be displayed for a clinician or physician; for example, the detectedcondition or state may be displayed on a display of the device 100. Thedevice 100 may be compact and/or lightweight for the same reasonsdescribed above in reference to the unit 10.

Techniques used to diagnose/measure in the device include but are notlimited to gas chromatography/capillary GC, liquid chromatography(HPLC/UHPLC), multidimensional chromatography, DNA/RNA sequencing,biophotonic sensors/photometry, biospectroscopy, single cell/multicellflow cytometry, optical microscopy, optical analysis with remote andautomated/televised monitoring, mass spectroscopy, IR spectroscopy,antibody labeled ELIZA, gas volatile and non-volatile analysis, smallmolecule/protein, peptide, carbohydrate hydrocarbon analysis, chemicalvapor deposition, calimetry, bioluminensence/luminensence, ion exchange,or any other analytical bio/radio/histochemistry technique that could beused to measure exhaled breath condensate.

As illustrated in FIG. 7, the device 100 may be a separate or standalonedevice or unit relative to, for example, the unit 10. The device 100 mayinject particles into the ventilator circuit as part of an inhaled gasflow IG. The injection may be timed to occur as the patient is inhaling;for example, this may be accomplished using the gas flow sensor (FIG.5). After the patient has inhaled the particles and then exhaled, anexhaled gas flow EG may be measured using an exhaled gas measurementsensor 110. The exhaled gas measurement sensor 110 is positioned in theventilator circuit and may be disposed between the patient and thediagnostic device 100. The exhaled gas measurement sensor 110 measuresexhaled breath condensate using one or more of the techniques describedabove. For example, the amount or concentration of exhaled “waste gas”could be measured after the particles have been administered.

A physiological reading or measurement (or exhaled gas measurement EGM)is communicated from the sensor 110 to the device 100. The EGM may becommunicated to a controller within the device 100 or may also becommunicated to an outside device for further processing. The controlleror outside device determines a specific state or condition of thepatient based on the EGM. The controller may then adjust a medicationdosing or timing based on the specific state or condition of thepatient. The device 100 may include a display (not shown) which maydisplay parameters related to the determined specific state or conditionof the patient and/or the current medication dosing or frequency and/orany adjustment thereto.

As illustrated in FIG. 7, the device 100 may be in communication withthe automated medication and control delivery unit 10. The device 100may communicate the specific state or condition of the patient to theMDI unit 10 (or to the controller of the unit 10) such that dosing ortiming of dosing may be adjusted from the unit 10. Alternatively, theexhaled gas measurement EGM may be communicated directly to the unit 10or controller therein for processing to determine the specific state orcondition of the patient, at which point the unit 10 may adjust thedosing or frequency of dosing accordingly. The display 28 on the unit 10(FIG. 1) may display parameters related to the determined specific stateor condition of the patient and/or the current medication dosing orfrequency and/or any adjustment thereto.

It is also contemplated that the diagnostic device 100 could beintegrated with an automated medication and control delivery unit as asingle unit or device. That is, the device 100 (or some or all of itsfeatures) may be integrated with any of the units 10, 10′, 10″, 10′″described herein. By way of example, referring to FIG. 2, one of theinhalers 12A, 12B of the unit 10′ may take the form of a containercontaining the diagnostic particles described above for injection aspart of the inhaled gas. The subsequently exhaled gas, may be measuredusing a sensor in the ventilator circuit and the exhaled gas measurementmay be communicated to the controller of the unit 10′. The specificstate or condition of the patient may be determined by the controller inresponse to the exhaled gas measurement and the controller may thenregulate or control the medication dosage or frequency from the other ofthe inhalers 12A, 12B responsive to the determined specific state orcondition.

The foregoing is illustrative of the present invention, and is not to beconstrued as limiting thereof. Although exemplary embodiments of thisinvention have been described, those skilled in the art will readilyappreciate that many modifications are possible in the exemplaryembodiments without materially departing from the novel teachings andadvantages of this invention. As such, all such modifications areintended to be included within the scope of this invention. The scope ofthe invention is to be defined by the following claims.

That which is claimed is:
 1. A system for providing automated deliveryof medication to a ventilator circuit that extends between a mechanicalventilator and a patient, the system comprising: a connector thatresides in-line with a portion of the ventilator circuit; a portablemedication delivery unit attached to the connector, the portabledelivery unit comprising: a housing releasably holding an upper endportion of at least one metered dose inhaler (MDI) canister containingmedication such that a major portion of the canister extends outside thehousing, wherein the canister includes an outlet nozzle residing belowand opposite the upper end portion that is received through an entryport in the connector such that the canister is in fluid communicationwith the ventilator circuit; and an actuator held by the housing and incommunication with the canister to direct the canister to releasemedication to the ventilator circuit for the patient, wherein theactuator is disposed adjacent the upper end portion of the canister; anda control device in communication with the portable delivery unit, thecontrol device configured to control an amount and/or frequency ofmedication delivery from the canister to the ventilator circuit for arespective patient and to direct the actuator to actuate and deliver themedication from the canister to the ventilator circuit at a definedamount and/or frequency.
 2. The system of claim 1, wherein the portabledelivery unit is releasably attached to the connector such that thehousing is adjacent and/or on the connector with the connector extendingcompletely outside the housing.
 3. The system of claim 1, wherein theportable delivery unit is a compact, lightweight device.
 4. The systemof claim 1, wherein the control device comprises a user interface toallow an operator to input to the control device the amount and/orfrequency of medication delivery from the canister to the ventilatorcircuit for the patient.
 5. The system of claim 4, wherein the userinterface comprises a manual override control to direct the actuator toactuate to deliver medication from the canister to the ventilatorcircuit for a respective patient irrespective of the defined amountand/or frequency of medication delivery.
 6. The system of claim 1,wherein the control device comprises a display for displaying parametersincluding the defined amount and/or frequency of medication delivery andan amount of medication remaining in the canister, wherein the controldevice is configured to dynamically update the displayed parameters. 7.The system of claim 1, wherein the control device is a handheldelectronic device.
 8. The system of claim 7, wherein the control deviceis in wireless communication with the delivery unit.
 9. The system ofclaim 1, further comprising a gas flow sensor disposed in the interiorof the connector, the gas flow sensor configured to detect a gas flowdirection through the connector and communicate the gas flow directionto the control device.
 10. The system of claim 9, wherein the controldevice is configured to direct the actuator to actuate to delivermedication from the canister to the ventilator circuit when the gas flowdirection in the connector is from the ventilator to the patient basedon data detected by the gas flow sensor.
 11. The system of claim 9,wherein the gas flow sensor is configured to detect at least one gasflow characteristic of gas flowing through the connector and tocommunicate the detected at least one gas flow characteristic to thecontrol device, and wherein the control device is configured to adjustthe amount and/or frequency of medication delivery in response to thedetected at least one gas flow characteristic.
 12. The system of claim1, further comprising a gas flow sensor disposed in the ventilatorcircuit, the gas flow sensor configured to detect a gas flow directionthrough the ventilator circuit and communicate the gas flow direction tothe control device, wherein the control device is configured to directthe actuator to actuate and deliver medication from the canister to theventilator circuit in response to the gas flow sensor detecting a gasflow direction from the ventilator to the patient.
 13. The system ofclaim 1, wherein the control device is configured to: (i) lock the unitto prevent actuation of the actuator and prevent unwanted adjustment ofoperational parameters; (ii) receive identification informationassociated with an operator of the unit; (iii) verify that the operatoris an authorized user based on the identification information; and (iv)unlock the unit and direct the actuator to actuate and delivermedication from the canister to the ventilator circuit in response toverification that the operator is an authorized user.
 14. The system ofclaim 1, wherein the control device is configured to: (i) lock the unitto prevent actuation of the actuator and prevent unwanted adjustment ofoperational parameters; (ii) receive identification informationassociated with a patient; (iii) verify that the patient is to receivethe medication contained in the canister based on the identificationinformation; and (iv) unlock the unit and direct the actuator to actuateand deliver medication from the canister to the ventilator circuit inresponse to verification that the patient is to receive the medicationcontained in the canister.
 15. The system of claim 1, wherein thecontrol device is configured to: (i) lock the unit to prevent actuationof the actuator and prevent unwanted adjustment of operationalparameters; (ii) receive identification information associated with thepatient; (iii) electronically identify the canister that is held by thehousing; (iv) verify that the patient is to receive the medicationcontained in the canister based on the identification informationassociated with the patient and the electronic identification of thecanister; and (v) unlock the unit and direct the actuator to actuate anddeliver medication from the canister to the ventilator circuit inresponse to verification that the patient is to receive the medicationcontained in the inhaler.
 16. The system of claim 1, wherein thedelivery unit is releasably attached to the connector by at least oneholding member that holds the housing in place.
 17. The system of claim1, wherein the delivery unit comprises an identification deviceconfigured to electronically identify the canister held by the housing.